An Open-Label Study to Assess the Two-Way Interaction Between Multiple Weekly Doses of MK-8507 and Single Doses of Islatravir (MK-8591) in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
研究概览
简要总结
The main goals of this study are to learn what happens to Islatravir or MK-8507 in a person's body over time. Researchers will compare Islatravir given alone to Islatravir given with MK-8507. Researchers will also compare MK-8507 given alone to MK-8507 given with Islatravir.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Has a history of cancer with protocol specified exceptions
研究组 & 干预措施
Islatravir+MK-8507
Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29.
干预措施: MK-8507 (Drug)
Islatravir+MK-8507
Period 1: Participants receive single dose of Islatravir on Day 1. Period 2: Participants receive single dose of MK-8507 on Days 1 and Days 8. Period 3: Participants receive single dose of Islatravir and single dose of MK-8507 on Day 1, 7 days after the Day 8 dose of MK-8507, during Period 2. Participants will receive additional MK-8507 single doses on Days 8, 15, 22, and 29.
干预措施: Islatravir (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Islatravir Metabolite
时间窗: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine the AUC0-Inf of Islatravir metabolite.
Area Under the Concentration-Time Curve from Time 0 to 168 hours (AUC0-168hrs) of Islatravir Metabolite
时间窗: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the AUC0-168hrs of Islatravir metabolite.
Maximum Concentration (Cmax) of Islatravir Metabolite
时间窗: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine Cmax of Islatravir metabolite.
Plasma Concentration at 168 Hours (C168) of Islatravir Metabolite
时间窗: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the C168 of Islatravir metabolite.
Time to Maximum Concentration (Tmax) of Islatravir Metabolite
时间窗: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine the Tmax of Islatravir metabolite.
Apparent Terminal Half-life (t1/2) of Islatravir Metabolite
时间窗: At designated timepoints (up to approximately 43 days)
Blood samples will be collected to determine the t1/2 of Islatravir metabolite.
AUC0-Inf of Islatravir
时间窗: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the AUC0-Inf of Islatravir.
AUC0-168hrs of Islatravir
时间窗: At designated timepoints (up to approximately 7 days)
Blood samples will be collected to determine the AUC0-168hrs of Islatravir.
Cmax of Islatravir
时间窗: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine Cmax of Islatravir.
C168 of Islatravir
时间窗: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the C168 of Islatravir.
Tmax of Islatravir
时间窗: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the Tmax of Islatravir.
t1/2 of Islatravir
时间窗: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the t1/2 of Islatravir.
Apparent clearance (CL/F) of Islatravir
时间窗: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the CL/F of Islatravir.
Vd/F of MK-8507
时间窗: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the Vd/F of MK-8507.
Apparent Volume of Distribution During Terminal Phase (Vd/F) of Islatravir
时间窗: At designated timepoints (up to approximately 22 days)
Blood samples will be collected to determine the Vd/F of Islatravir.
AUC0-168hrs of MK-8507
时间窗: At designated timepoints (up to approximately 7 days)
Blood samples will be collected to determine the AUC0-168hrs of MK-8507.
Cmax of MK-8507
时间窗: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine Cmax of MK-8507.
C168 of MK-8507
时间窗: At designated timepoints (up to approximately 168 hours)
Blood samples will be collected to determine the C168 of MK-8507.
Tmax of MK-8507
时间窗: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the Tmax of MK-8507.
t1/2 of MK-8507
时间窗: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the t1/2 of MK-8507.
CL/F of MK-8507
时间窗: At designated timepoints (up to approximately 15 days)
Blood samples will be collected to determine the CL/F of MK-8507.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 5 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 5 months)